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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CLEARSTREAM TECHNOLOGIES LTD. SLEEK RX PTA BALLOON DILATATION CATHETER

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CLEARSTREAM TECHNOLOGIES LTD. SLEEK RX PTA BALLOON DILATATION CATHETER Back to Search Results
Model Number 425-2015X
Device Problems Failure to Advance; Material Deformation
Event Date 03/14/2018
Event Type  Malfunction  
Manufacturer Narrative

Manufacturing review: the lot number was provided and the lot device history records have been reviewed. The lot met all release criteria. There was nothing found to indicate there was a manufacturing related cause for this event. This is the only complaint that has been reported for this corporate lot number to date for this failure mode. Investigation summary: the result of the investigation is confirmed for the failure to advance failure mode reported. There was a kink observed on the inner at the proximal cone area of the balloon. These may have contributed to the reported event. The guidewire could not advance past the kink during evaluation. It is unlikely that the kinks are manufacturing related, as a 100% visual inspection for catheter kinks is performed. A guidewire check is also performed on 100% of devices during catheter production. The manufacturing documentation was reviewed and showed no anomalies with the manufacture of this lot to suggest a product issue. Finally it is unknown whether handling or procedural techniques contributed to the reported event. The definitive root cause for the reported advancement issue could not be determined based upon available information. Labeling review: ifu for sleek pta rapid exchange (rx) dilatation catheter product family was reviewed the following sections are applicable: description: the sleek® percutaneous transluminal angioplasty (pta) peripheral catheter family comprise a range of sizes of rapid exchange catheters for peripheral angioplasty. The catheter¿s proximal tubing is 304v stainless steel and the distal coaxial tubings are nylon co-polymer blend. The lumen of the shaft is used for the purpose of inflating and deflating the balloon. A second lumen at the tip is used for advancing the guidewire. A 0. 014¿ (0. 356 mm) guidewire is recommended for use with the sleek® catheters. Warnings: do not advance the guidewire, balloon dilation catheter, or any component if resistance is met, without first determining the cause and taking remedial action. Precautions: carefully inspect the catheter prior to use to verify that the catheter has not been damaged during shipment and that its size, shape and condition are suitable for the procedure for which it is to be used. Do not use if product damage is evident. Careful attention must be paid to the maintenance of tight catheter connections to avoid the introduction of air into the system. Directions for use: inspection and preparation remove the balloon sleeve by first withdrawing the shipping mandrel slightly and then slowly removing the sleeve while holding the catheter as close to the balloon as possible. If any resistance is felt, or if any stretching of the catheter is observed while removing the balloon sleeve, the product should not be used. The catheter should then be inspected for bends, kinks or stretched portions. Do not use if product damage is evident. Procedure: insertion and inflation note: a 0. 014¿ (0. 356 mm) guidewire must be inserted in the sleek® catheter across the balloon during any inflation of the balloon. (1) attach a haemostatic valve to the appropriate guiding catheter/sheath, which has been previously inserted into the vasculature following standard product guidelines. (2) insert the guidewire (0. 014¿ (0. 356 mm) max) into the guiding catheter/sheath through the haemostatic valve. Under fluoroscopy, position the guidewire across the lesion in accordance with accepted pta techniques. (3) make sure that the balloon sleeve has been removed from the catheter balloon. Back load the guidewire into the distal tip of the dilation catheter. (4) advance the dilation catheter in small steps to the tip of the guiding catheter/ sheath. (5) re-attach the torque device to the guidewire. Hold the guidewire stationary and advance the balloon catheter over the guidewire and across the stenosis.

 
Event Description

It was reported that the pta balloon catheter allegedly failed to cross the lesion. There was no reported patient injury.

 
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Brand NameSLEEK RX PTA BALLOON DILATATION CATHETER
Type of DevicePTA BALLOON DILATATION CATHETER
Manufacturer (Section D)
CLEARSTREAM TECHNOLOGIES LTD.
moyne upper
enniscorthy, co. wexford
EI 
Manufacturer (Section G)
CLEARSTREAM TECHNOLOGIES LTD.
moyne upper
enniscorthy, co. wexford
EI 
Manufacturer Contact
judith ludwig
1625 w 3rd st.
tempe , AZ 85281
4803032689
MDR Report Key8021116
Report Number9616666-2018-00153
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 10/30/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/30/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/31/2018
Device MODEL Number425-2015X
Device Catalogue Number425-2015X
Device LOT Number50127668
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/01/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/03/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/19/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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